Biosafety Applications

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Biosafety applications can be divided into two key categories, depending on whether or not the work proposed will involve genetically modified organisms (GMOs).

1. Applications for work with GMOs

Attention: The Gene Technology Regulations 2001, amendment 2011, commenced on 1 September 2011. As such, all new applications must comply with the new definitions and the new classifications for GMO dealings. Please ensure that you have consulted a copy of the new Gene Technology Amendment Regulations 2011 before submitting your application.

Information to Access Before Applying

For information on the requirements for dealings with GMOs we recommend researchers first visit the website of the Office of the Gene Technology Regulator (OGTR), in order to gain the most up to date information on requirements. At the site you will find information on:

• what constitutes a GMO 'dealing'
• the classes of dealings involving GMOs
• and what dealings are considered to be:
  • Exempt Dealings
  • Notifiable Low Risk Dealings (NLRDs)
  • Dealings Not involving an Intentional Release (DNIRs)
  • Dealings Involving an Intentional Release (DIRs)

Further guidance on OGTR matters can be gained by discussing the proposed work with the Research Ethics Unit or your Faculty/Institute representative on the Institute Biosafety Committee (IBC).

NLRD & Exempt Applications

Determination on whether work meets the requirements of being NLRD or Exempt is made by the IBC. If the work is deemed to fall into either of these categories approval can be issued by the IBC, with no further review by OGTR required.

• Application Form - NLRD + Exempt Dealings

Exempt applications are considered by the Chair, IBC on an ongoing basis. NLRD applications however must be assessed by the full IBC. The dates submissions must be received by the Research Ethics Unit to ensure their consideration at the associated IBC meeting are outlined below.

DNIR & DIR Licence Applications

These dealings must be licensed by the Gene Technology Regulator (the Regulator). Application forms for DNIR and DIR licences are available from the OGTR website. Prior to submission to the OGTR, a licence application must be reviewed and endorsed by the IBC. The dates submissions must be received by the Research Ethics Unit to ensure their consideration at the associated IBC meeting are outlined below.

Once the application is received by the OGTR they will conduct their own review before issuing (or refusing to issue) a licence. Please see the OGTR website for expected review timeframes.

2012 Submission and IBC Meeting Dates

Note that the IBC also holds e-meetings on an as required basis, to ensure the timely review of applications recieved. Please contact the Research Ethics Unit if you require further information or wish to discuss.

2. Applications for work with non-GMO biosafety materials

Applications for work with non-GMO bioasfety materials are assessed at a Faculty/Institute level, in consultation with your Facility/Laboratory Manager. The Biosafety Application Flowchart has been developed to assist you in deciding what documentation you need to submit.

Please contact your local Workplace Health & Safety Officer or Laboratory Manager for guidance.